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Clinical Trials/NCT01452321
NCT01452321
Completed
Phase 2

Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression

University of Sao Paulo General Hospital1 site in 1 country14 target enrollmentAugust 2007

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Depression, Postpartum
Sponsor
University of Sao Paulo General Hospital
Enrollment
14
Locations
1
Primary Endpoint
Hamilton Depression Rating Scale (HDRS)
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of postpartum depression.

However, up to current days there have been no studies evaluating the effects of rTMS on neurocognitive and social performance of women suffering from the disorder.

The present study evaluates the impacts of rTMS in clinical, cognitive and social performance.

Detailed Description

Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects. The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes. Side effects include scalp discomfort and mild headache. No anesthesia is required. Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
September 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eduardo Moacyr Krieger

Associate Professor

University of Sao Paulo General Hospital

Eligibility Criteria

Inclusion Criteria

  • major depression with a puerperal onset, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0)
  • baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
  • baseline score of at least 13 points on the Edinburgh Postnatal Depression Scale.
  • range = 18-36 years
  • women who had given birth 1-6 months
  • any pharmacological treatment other than clonazepam (1 mg/day)

Exclusion Criteria

  • comprised ferromagnetic metallic implants
  • pacemakers
  • previous neurosurgery
  • history of seizures
  • major head trauma
  • alcoholism
  • drug addiction
  • any psychiatric or neurological disorder other than depression and anxiety
  • psychotic depression
  • suicidal propensities

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HDRS)

Time Frame: 6 weeks

Reduction on the scores of HDRS (as on the scores of Edinburgh Pospartum Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life)

Secondary Outcomes

  • Battery of Neuropsychological Tests and Social Adjustment Scale(6 weeks)

Study Sites (1)

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